EMEA Regional Quality Integration Leader
Il y a 4 heures
Aalst, Flanders, Belgique
BD
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pAs a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide. /ppWe are the people who give possibilities purpose /ppBD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. /ph3Job Description /h3h3About the Role /h3pThe EMEA Regional Quality Integration Leader will be responsible for leading and coordinating quality integration activities across the Europe, Middle East, and Africa regions, ensuring adherence to regulatory requirements and internal quality standards following mergers, acquisitions, or significant process changes. This is an outstanding opportunity to develop the quality landscape of our organization in a region that spans multiple countries and regulatory environments. /ph3Main Responsibilities will include /h3ulliDevelop and carry out regional quality integration strategies and plans that align with global quality objectives and local regulatory frameworks. /liliGuide cross-functional teams through the integration of quality management systems (QMS), processes, and procedures for newly acquired entities or major business changes within the EMEA region. /liliConduct gap analyses of existing quality systems against BD standards and applicable regulations (e.g., ISO 13485, MDR, IVDR), developing and implementing remediation plans. /liliHarmonization of quality documentation, training programs, and quality metrics coordinated across integrated sites. /liliAct as the primary point of contact for quality integration matters with regional business leaders, global quality teams, and regulatory affairs. /liliEnsure effective communication and change management strategies are in place to support successful quality integration. /liliMonitor and report on the progress of quality integration initiatives, identifying and mitigating potential risks. /liliParticipate in due diligence activities for potential acquisitions from a quality perspective. /liliProvide expert mentorship and support on quality integration challenges to regional teams. /liliFoster a culture of continuous improvement and quality excellence throughout the integration process. /li /ulh3About you /h3ulliBachelor's degree or equivalent experience in a scientific, engineering, or related field. Master's degree preferred. /liliMinimum of 8-10 years of experience in Quality Assurance in the medical device or pharmaceutical industry. At least 3-5 years must be in a leadership or management role. /liliEstablished background in guiding and handling quality system integrations associated with mergers, acquisitions, or substantial organizational shifts. /liliComprehensive understanding of applicable medical device regulations (e.g., ISO 13485, EU MDR, IVDR, FDA QSR). /liliSolid knowledge of quality management concepts, tools, and approaches (e.g., CAPA, FMEA, lean manufacturing). /liliProven capability to guide and impact cross-functional teams within a complex, matrixed organization. /liliExcellent communication, interpersonal, and presentation skills with the ability to engage collaborators at all levels. /liliStrong analytical and problem-solving abilities. /liliFluency in English required; proficiency in other major European languages (e.g., German, French) is a significant advantage. /liliWillingness to travel regularly throughout the EMEA region (up to 40-50%). /li /ulpThis role is perfect for someone who thrives in a dynamic environment and is excited by the challenge of integrating quality systems across diverse regions and cultures. Join us and be a part of a team that is committed to clinical excellence and patient safety /ph3Why Join Us? /h3pTo find purpose in the possibilities, we need people who can see the bigger picture, who u